This invention relates to apparatus and a method for applying electrical energy to living tissue, and more particularly, to apparatus and a method for stimulating penile erectile tissue and a method of making such apparatus.
As is well known, the erectile tissue of the penis is composed of hollow sinuses, the walls of which contain involuntary muscle tissue. Blood reaches the sinuses through arterioles and capillaries, and the outlets from the sinuses are also controlled by involuntary muscle. In erection, impulses from the pelvic nerve cause dilation of the arterioles and constriction of the involuntary muscle controlling the outlets from the sinuses. The combined effect of these actions is to dilate the vascular spaces and to create high pressure within them, causing hardening and erection of the organ.
Normal erection is dependent upon a complex interaction of psychological, neurological and vascular factors. Failure of any of them can result in an inability to sustain erection, a condition commonly referred to as male impotence.
It has been suggested that, in the case of individuals whose impotence is a result of certain neurological deficits, the application of external electrical stimulus may ameliorate the impotence. Thus, for example, in U.S. Pat. No. 3,403,684, issued Oct. 1, 1968, to Stiebel, et al., a device was suggested in which a pair of electrodes were placed in the area of the prostate gland of a user, and it was proposed that an electrical signal be applied to the electrodes to cause electrical stimulation of the surrounding tissues.
It has now been demonstated in laboratory animals that stimulation can best be accomplished by applying an electrical stimulus as directly as possible to certain highly sensitive and identifiable areas of the prostate gland. It is believed that if the signal is applied to these areas, the precise locations of which will vary from individual to individual, the nature of the signal is less critical than was formerly thought, and the desired results can be consistently and reliably obtained.
It is, therefore, a general object of this invention to provide apparatus and a method for stimulating erectile tissue, and more particularly apparatus and a method which are useful to promote penile erection by electrical stimulation.
Another object of this invention is to provide a method of making apparatus for stimulating penile erection, and it is still another object of the invention to provide a genital stimulator which is compact, self-contained, and capable of being accurately placed and positioned for use.
Another object of this invention is to provide a genital stimulator which is maintained in position for use by the anatomical structures, particularly the musculature, which surround it when it is positioned for use.
Other objects will appear hereinafter.
The foregoing and other objects are realized, in a presently preferred form of the apparatus, by a stimulator which comprises a body member, the shape of which is determined by an impression molded in situ, and which is adapted for insertion into the rectum of a user. Molding in the above manner ensures that the body member is so configured as to closely conform to the unique configuration of the rectum of each user. Within the body member there is placed a highly miniaturized electrical signal generator, and electrodes are disposed at carefully selected localities on the outer surface of the body member. In accordance with the present invention, at least one electrode is juxtaposed as closely as possible to a selected spot on the prostate of the user which has been determined to be sensitive to electrical stimulation. Close conformity of the body member to the configuration of the rectum of the user, as well as a unique homeostatic effect described below, maintains the electrode in close proximity to the sensitive spot, and assures application of electrical impulses to that spot to stimulate erection. Electrical signals are generated by signal generating circuitry disposed within a cavity in the body member, and the body member, signal generating circuitry and its associated power supply are self-contained. Actuation of the apparatus may be by means of a manually operated or magnetically activated switch associated with the body member, or by remote telemetric means.
In its method aspect, the present invention involves palpation of the prostate gland of a potential user and application to the prostate, at selected spots, of an electrical impulse. The result of the application of the impulse at the selected spot can be sensed or observed, and determines for the clinician the efficacy of application of electrical stimulus to that spot. When the sensitive spot or spots of the prostate have been identified, an impression is taken of the rectum of the user in at least the region extending from the anus to a location proximate to the prostate gland, and from that impression, a body member closely conforming to the shape of the rectum can be made. Electrodes are positioned on the body member at locations corresponding to the previously identified sensitive spot or spots, and at other locations which provide suitable electrical contact with the tissues of the user.
The method of making the apparatus involves the taking of an impression of the rectum of the potential user by inserting into the rectum a sheath; injecting a molding composition into the sheath; permitting the molding composition to become somewhat hard; withdrawing the sheath slightly and permitting the composition to further harden; and then removing the sheath and the impression when the composition has fully hardened. The hardened composition thus forms an impression closely conforming to the configuration of the rectum, from which the body member of the apparatus may be molded. Electrodes can then be applied to the body member in positions corresponding to the sensitive spots on the prostate as earlier determined by palpation and stimulation, and electrical circuitry may be placed within the body member to produce the above-described apparatus.
There are seen in the drawings forms of the invention which are presently preferred (and which represent the best mode contemplated for carrying the invention into effect), but it should be understood that the invention is not limited to the precise arrangements and instrumentalities shown.